For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risk then validate that users can use the device safety and effectively.  

For products marketed in the United States, the FDA is the regulatory body.  For products marketed in other regions such as the European Union, local regulatory authorities provide oversight.  

If you need a regulatory team, we can provide that service.  

Folow the links below for regulatory, ISO, and CE marking resources.

Call us at 512 663 5681

Our team Will Help You Navigate FDA Requirements, ISO/IEC,

& CE Marking of Your Products and Devices

Call us at 512 663 5681

Other Resources